URINARY BLADDER CARCINOMA STRUCTURED REPORTING PROTOCOL

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URINARY BLADDER CARCINOMA
STRUCTURED REPORTING
PROTOCOL
(RADICAL CYSTECTOMY, PARTIAL
CYSTECTOMY, CYSTOPROSTATECTOMY)
(1st Edition 2012)
Core Document versions:
•
•
AJCC Cancer Staging Manual 7th edition (including errata corrected with 5th
reprint 10th Aug 2010).
World Health Organization Classification of Tumours Pathology and genetics:
Tumours of the Urinary System and Male Genital Organs. Volume 7, 2004.
1
ISBN: 978-1-74187-704-5
Publications number (SHPN): (CI) 120055
Online copyright
© RCPA 2012
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4.
In regard to Chapter 6 of the Protocol - the checklist:
o
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o
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o
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o
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o
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o
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should be addressed to RCPA, 207 Albion St, Surry Hills, NSW 2010, Australia.
First published: April, 2012, 1st Edition (Version 1.0)
2
Disclaimer
The Royal College of Pathologists of Australasia ("College") has developed these
protocols as an educational tool to assist pathologists in reporting of relevant information
for specific cancers. While each protocol includes “standards” and “guidelines” which are
indicators of ‘minimum requirements’ and ‘recommendations’, the protocols are a first
edition and have not been through a full cycle of use, review and refinement. Therefore,
in this edition, the inclusion of “standards” and “guidelines” in each document are
provided as an indication of the opinion of the relevant expert authoring group, but
should not be regarded as definitive or as widely accepted peer professional opinion.
The use of these standards and guidelines is subject to the clinician’s judgement in each
individual case.
The College makes all reasonable efforts to ensure the quality and accuracy of the
protocols and to update the protocols regularly. However subject to any warranties,
terms or conditions which may be implied by law and which cannot be excluded, the
protocols are provided on an "as is" basis. The College does not warrant or represent
that the protocols are complete, accurate, error-free, or up to date. The protocols do
not constitute medical or professional advice. Users should obtain appropriate medical
or professional advice, or where appropriately qualified, exercise their own professional
judgement relevant to their own particular circumstances. Users are responsible for
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the protocols.
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3
Contents
Scope ................................................................................................................. v
Abbreviations ..................................................................................................... 6
Definitions.......................................................................................................... 7
Introduction ..................................................................................................... 10
Authority and development .............................................................................. 13
1
Pre-analytical ......................................................................................... 16
2
Specimen handling and macroscopic findings ........................................ 18
3
Microscopic findings ............................................................................... 22
4
Ancillary studies findings ....................................................................... 26
5
Synthesis and overview ......................................................................... 27
6
Structured checklist ............................................................................... 29
7
Formatting of pathology reports ............................................................ 50
Appendix 1
Pathology request information and surgical handling
procedures ......................................................................... 51
Appendix 2
Guidelines for formatting of a pathology report ................. 55
Appendix 3
Example of a pathology report ............................................ 56
Appendix 4
WHO Classification of Tumours of the Bladder
Carcinoma4 ......................................................................... 58
Appendix 5
AJCC Cancer Staging System .............................................. 60
References ....................................................................................................... 62
4
Scope
This protocol contains standards and guidelines for the preparation of structured
reports for bladder tumours in adults. The guidelines can be used in the reporting
of radical cystectomy, partial cystectomy and cystoprostatectomy but does not
include information on the handling and reporting of primary lymphadenectomy
specimens.
Structured reporting aims to improve the completeness and usability of pathology
reports for clinicians, and improve decision support for cancer treatment. The
protocol provides the framework for the reporting of any bladder tumour, whether
as a minimum data set or fully comprehensive report.
v
Abbreviations
LG
Low grade
AJCC
American Joint Committee on Cancer
CIS
Carcinoma in situ
HG
High grade
TCC
Transitional cell carcinoma
LIS
Laboratory Information System
LVI
Lymphovascular invasion
PBS
Pharmaceutical Benefits Scheme
UC
Urothelial carcinoma
RCPA
Royal College of Pathologists of Australasia
TNM
Tumour-node-metastasis
UICC
International Union Against Cancer
WHO
World Health Organization
6
Definitions
The table below provides definitions for general or technical terms used in this
protocol. Readers should take particular note of the definitions for ‘standard’,
‘guideline’ and ‘commentary’, because these form the basis of the protocol.
Ancillary study
An ancillary study is any pathology investigation that may
form part of a cancer pathology report but is not part of
routine histological assessment.
Clinical
information
Patient information required to inform pathological
assessment, usually provided with the specimen request
form, also referred to as “pre-test information”.
Commentary
Commentary is text, diagrams or photographs that clarify the
standards (see below) and guidelines (see below), provide
examples and help with interpretation, where necessary (not
every standard or guideline has commentary).
Commentary is used to:
•
define the way an item should be reported, to foster
reproducibility
•
explain why an item is included (e.g. how does the
item assist with clinical management or prognosis of
the specific cancer).
•
cite published evidence in support of the standard or
guideline
•
state any exceptions to a standard or guideline.
In this document, commentary is prefixed with ‘CS’ (for
commentary on a standard) or ‘CG’ (for commentary on a
guideline), numbered to be consistent with the relevant
standard or guideline, and with sequential alphabetic lettering
within each set of commentaries (eg CS1.01a, CG2.05b).
7
General
commentary
Guideline
General commentary is text that is not associated with a
specific standard or guideline. It is used:
•
to provide a brief introduction to a chapter, if
necessary
•
for items that are not standards or guidelines but are
included in the protocol as items of potential
importance, for which there is currently insufficient
evidence to recommend their inclusion. (Note: in
future reviews of protocols, such items may be
reclassified as either standards or guidelines, in line
with diagnostic and prognostic advances, following
evidentiary review).
Guidelines are recommendations; they are not mandatory, as
indicated by the use of the word ‘should’. Guidelines cover
items that are not essential for clinical management, staging
or prognosis of a cancer, but are recommended.
Guidelines include key observational and interpretative
findings that are fundamental to the diagnosis and
conclusion. Such findings are essential from a clinical
governance perspective, because they provide a clear,
evidentiary decision-making trail.
Guidelines are not used for research items.
In this document, guidelines are prefixed with ‘G’ and
numbered consecutively within each chapter (eg G1.10).
Macroscopic
findings
Measurements or assessment of tissues made by the unaided
eye.
Microscopic
findings
Findings of histological assessment.
Predictive factor
A predictive factor is a measurement that is associated with
response or lack of response eg. to a particular therapy.
Prognostic factor
A prognostic factor is a measurement that is associated with
clinical outcome in the absence of therapy or with the
application of a standard therapy. It can be thought of as a
measure of the natural history of the disease.
8
Standard
Standards are mandatory, as indicated by the use of the term
‘must’. Their use is reserved for core items essential for the
clinical management, staging or prognosis of the cancer and
key information (including observations and interpretation)
which is fundamental to the diagnosis and conclusion. These
elements must be recorded and at the discretion of the
pathologist included in the pathology report according to the
needs of the recipient of the report.
The summation of all standards represents the minimum
dataset for the cancer.
In this document, standards are prefixed with ‘S’ and
numbered consecutively within each chapter (eg S1.02).
Structured report
A report format which utilises standard headings, definitions
and nomenclature with required information.
Synoptic report
A structured report in condensed form (as a synopsis or
precis).
Synthesis
Synthesis is the process in which two or more pre-existing
elements are combined, resulting in the formation of
something new.
The Oxford dictionary defines synthesis as “the combination
of components or elements to form a connected whole”.
In the context of structured pathology reporting, synthesis
represents the integration and interpretation of information
from two or more modalities to derive new information.
9
Introduction
Cancer of the urinary bladder is the ninth most common cancer worldwide with
357 000 new cases reported in 2002. It is the 13th most common cause of death
from cancer.1 Males are affected 3-4 times more commonly than females. The
incidence of bladder cancer is high in many Southern and eastern European
countries, parts of Africa, the Middle East, and in the USA. The highest mortality
is in Egypt where the rates are more than 3 times that in Europe and 8 times that
seen in the USA. In Western countries, the incidence of invasive cancer has
decreased whereas the combined incidence of in situ and invasive cancer has
increased over the years. There has been an overall decrease in mortality.
In Australia, 2367 bladder cancer cases were newly diagnosed and there were
925 cancer deaths in 2007.2 Between 1983 and 2003, reduction in mortality rates
of 18%, with more pronounced decreases in men than women, have been found.
Bladder cancer occurs in older individuals with the median age at diagnosis of 73
years.3 Approximately 0.1% are diagnosed under age 20; 0.4% between 20 and
34; 1.7% between 35 and 44; 7.4% between 45 and 54; 18.0% between 55 and
64; 27.2% between 65 and 74; 32.0% between 75 and 84; and 13.2% 85+
years of age.3
The most common type of bladder cancer in developed countries including
Australia is urothelial carcinoma (UC) accounting for greater than 90% of bladder
cancers. Urothelial carcinoma (UC) includes papillary and invasive UC and
urothelial carcinoma in situ (CIS). Papillary urothelial neoplasms include
papillomas, papillary urothelial neoplasms of low malignant potential (LMP) and
low-grade (LG) and high-grade (HG) UC. Invasive carcinoma is typically high
grade. UC has the propensity for divergent differentiation resulting in a variety of
subtypes. Divergent differentiation is usually seen in association with high-grade
and high stage disease. A variety of other carcinomas including adenocarcinoma,
squamous cell carcinoma and small cell carcinoma are also seen.4 Standard
therapies for bladder cancer include surgery, radiation therapy, chemotherapy,
and immunotherapy or biological therapy. Accurate diagnosis and staging are
essential to select appropriate therapy for each case. Therefore it is important
that these specimens are handled and reported in a systematic manner.
Importance of histopathological reporting
Information in the pathology report of the macroscopic and microscopic findings
in cystectomy specimens (partial, total including radical cystoprostatectomy) is of
both clinical and prognostic utility. The information gained from these specimens
is used to guide clinical management of patients, particularly in relation to the
role of definitive and adjuvant therapy and surveillance.
While the report must contain all information necessary for tumour staging, the
treating clinician will often look for additional information in the report to further
refine the patient’s likely prognosis and optimal treatment.
10
Benefits of structured reporting
Structured pathology reports with standardised definitions for each component
have been shown to significantly enhance the completeness and quality of data
provided to clinicians and have been recommended both in North America and the
United Kingdom.5-9
The Royal College of Pathologists (UK) and the College of American Pathologists
have published protocols for the reporting of bladder cancers in 2009.10-11 In view
of the increasing support for, and interest in, structured pathology reporting, it is
clear that a protocol endorsed by the Royal College of Pathologists of Australasia
and other Australasian organisations involved in the management of bladder
cancer is required. In this protocol, we have incorporated recent developments in
the classification and behaviour of bladder cancers. It is hoped that the
document will provide pathologists with guidelines that are comprehensive and
easy to use and will provide clinicians with a data set that is appropriate to clinical
management in the local setting.
Design of this protocol
This structured reporting protocol defines all of the relevant features to be
assessed and recorded in a pathology report for bladder carcinoma. Mandatory
elements (standards) are differentiated from those that are not mandatory but
are recommended (guidelines). Consistency and speed of reporting is improved
by the use of discrete data elements recorded from the checklist. However, the
pathologist is encouraged to include free text or narrative to document any other
relevant issues, to give reasons for coming to a particular opinion and to explain
any points of uncertainty.
The structure provided by the following chapters, headings and subheadings
describes the elements of information and their groupings, but does not
necessarily represent the format of either a pathology report (Chapter 7) or
checklist (Chapter 6). These, and the structured pathology request form
(Appendix 1) are templates that represent information from this protocol,
organised and formatted differently to suit different purposes.
Key documentation
•
Guidelines for Authors of Structured Cancer Pathology Reporting Protocols,
Royal College of Pathologists of Australasia, 2009.12
•
Pathology and genetics: Tumours of the Urinary System and Male Genital
Organs. World Health Organisation Classification of Tumours, Volume 7,
2004.4
•
AJCC Cancer Staging Manual, 7th edition.13
11
Updates since last edition
Not applicable
12
Authority and development
This section provides details of the committee involved in developing this protocol
and the process by which it was developed.
Protocol developers
This protocol was developed by an expert committee, with assistance from
relevant stakeholders.
Expert committee
Associate Professor Hemamali Samaratunga, (Lead author), Pathologist
Dr David Clouston, Pathologist
Professor Brett Delahunt, Pathologist
Professor Warick Delprado, Pathologist
Dr David Grimes, Oncologist
Professor James Kench, Pathologist
Dr Joanna Perry-Keene, Pathologist
Dr John Yaxley, Urologist
International Liaison
Professor John R Srigley (Canada), Pathologist
Dr. Thomas Wheeler, Chair of the Genitourinary Tumours Cancer Committee,
College of American Pathologists.
Acknowledgements
The Bladder cancer expert committee wish to thank all the pathologists and
clinicians who contributed to the discussion around this document.
13
Stakeholders
ACT Health
Anatomical Pathology Advisory Committee (APAC)
Andrology Australia
Australian Association of Pathology Practices Inc (AAPP)
Australian Cancer Network
Australian Commission on Safety and Quality in Health Care
Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)
Cancer Australia
Cancer Control New Zealand
Cancer Council ACT
Cancer Council NSW
Cancer Council Queensland
Cancer Council SA
Cancer Council Tasmania
Cancer Council Victoria
Cancer Council Western Australia
Cancer Institute NSW
Cancer Services Advisory Committee (CanSAC)
Cancer Society of New Zealand.
Cancer specific expert groups – engaged in the development of the protocols
Cancer Voices
Clinical Oncological Society of Australia (COSA)
Department of Health and Ageing
Faculty of Radiation Oncology Genito-Urinary Group (FROGG)
Grampians Integrated Cancer Services (GICS)
Health Informatics Society of Australia (HISA)
Independent review group of pathologists
Medical Software Industry Association (MSIA)
National Coalition of Public Pathology (NCOPP)
National E-Health Transition Authority (NEHTA)
National Pathology Accreditation Advisory Council (NPAAC)
National Round Table Working Party for Structured Pathology Reporting of
Cancer.
NSW Department of Health
14
Queensland Cooperative Oncology Group (QCOG)
Representatives from laboratories specialising in anatomical pathology across
Australia
Royal Australasian College of Physicians (RACP)
Southern Cancer Network, Christchurch, New Zealand
Southern Melbourne Integrated Cancer Service (SMICS)
Standards Australia
The Medical Oncology Group of Australia
The Royal Australasian College of Surgeons (RACS)
The Royal Australian and New Zealand College of Radiologists (RANZCR)
The Royal Australian College of General Practitioners (RACGP)
The Royal College of Pathologists of Australasia (RCPA)
The Urological Society of Australia and New Zealand (USANZ)
Secretariat
Meagan Judge, Royal College of Pathologists of Australasia.
Development process
This protocol has been developed following the nine-step process set out in
Guidelines for Authors of Structured Cancer Pathology Reporting Protocols12
Where no reference is provided, the authority is the consensus of the expert
group.
15
1
Pre-analytical
This chapter relates to information that should be recorded on receipt of the
specimen in the laboratory.
The pathologist is reliant on the quality of information received from the clinicians
or requestor. Some of this information may be received in generic pathology
request forms; however, the additional information required by the pathologist
specifically for the reporting of Bladder cancer is outlined in Appendix 1. Appendix
1 also includes a standardised request information sheet that may be useful in
obtaining all relevant information from the requestor.
Surgical handling procedures affect the quality of the specimen and
recommendations for appropriate surgical handling are included in Appendix 1.
S1.01
S1.02
All demographic information provided on the request form and
with the specimen must be recorded.
CS1.01a
The Royal College of Pathologists of Australasia (RCPA) The
Pathology Request-Test-Report Cycle — Guidelines for
Requesters and Pathology Providers must be adhered to.14
This document specifies the minimum information to be
provided by the requesting clinician for any pathology test.
CS1.01b
The patient’s ethnicity must be recorded, if known. In
particular whether the patient is of aboriginal or Torres
Strait islander origin. This is in support of a government
initiative to monitor the health of indigenous Australians
particularly in relation to cancer.
CS1.01c
The patient’s health identifiers may include the patient’s
Medical Record Number as well as a national health number
such as a patient’s Medicare number (Australia), Individual
Healthcare Identifier (IHI) (Australia) or the National
Healthcare Identifier (New Zealand).
All clinical information as documented on the request form must
be recorded verbatim.
CS1.02a
The request information may be recorded as a single text
(narrative) field or it may be recorded atomically.
S1.03
The pathology accession number of the specimen must be
recorded.
S1.04
The principal clinician involved in the patient’s care and
responsible for investigating the patient must be recorded.
CS1.04a
Knowledge of the clinical presentation is an essential part
of the WHO classification yet it may not be available for a
number of reasons:
•
The clinical assessment and staging may be
16
incomplete at the time of procedure.
G1.01
•
The pathology request is often authored by the
clinician performing the procedure rather than the
clinician who is investigating and managing the
patient.
•
The identity of this clinician is often not indicated on
the pathology request form
•
In practice therefore, it is important in such cases
that the reporting pathologist should be able to
communicate with the managing clinician for
clarification.
Any clinical information received in other communications from the
requestor or other clinician should be recorded.
17
2 Specimen handling and macroscopic
findings
This section relates to the procedures required after the information has been
handed over from the requesting clinician, and the specimen has been received in
the laboratory.
Tissue Banking

Pathologists may be asked to provide tissue samples from fresh
specimens for tissue banking or research purposes. The decision to
provide tissue should only be made if the pathologist is sure that the
diagnostic process will not be compromised. As a safeguard, research
use of the tissue samples may be put on hold until the diagnostic
process is complete.
Specimen handling

The specimen must be handled in a systematic and thorough
fashion to ensure completeness and accuracy of pathological
data.

The ureteric and urethral resection margins must be examined
and any abnormalities identified.


•
It is essential that the ureteric and urethral resection margins
are examined to assess the adequacy of resection. Follow up
management may be influenced by this information.
•
It is important to identify any additional tumours in the
ureters and urethra to ascertain multifocality.
•
If any abnormalities are detected additional sections should
be taken.
The bladder should be opened, preferably anteriorly and fixed in
formalin.
•
It is easier to open the bladder anteriorly as the bladder is
often accompanied by other organs posteriorly.
•
As more bladder tumours are present posteriorly in the
bladder than anteriorly, there is less risk of tumour disruption
before macroscopic evaluation of the tumour.15
The tumour/tumours must be identified. The peritoneal surface
or perivesical fat resection margin deep to the tumour must be
18
examined for tumour involvement. This surface must be inked.
•

A minimum of three blocks of tumour must be taken, with at
least one block for every centimetre of the maximum
dimension and some including the deep margin. The ureteric
and urethral resection margins must be blocked.
•

It is important to grossly identify the maximum level of
invasion by the tumour (bladder wall or perivesical fat) for
accurate staging. Resection margin involvement is best
ascertained by inking the surgical margin. Perivesical fat
resection margin is examined to assess the adequacy of
resection. Peritoneal surface involvement may be associated
with peritoneal carcinomatosis.16
Tumour sampling must be generous to identify the highest
grade, any variants present and maximum depth of invasion.
It is important that blocks include the serosal surface or
perivesical soft tissue margin at the deepest part of the
tumour, as well as the adjacent bladder tissue to allow for the
assessment of LVI.
Sections of uninvolved bladder, trigone including ureteric
orifices, body and dome should be examined.
•
Examining sections of macroscopically uninvolved bladder is
useful in identifying multifocal urothelial CIS and foci of
unexpected tumour without a surface papillary component but
directly invasive. Rarely these foci can be more deeply
invasive than a grossly obvious tumour. Missing these foci can
be a problem particularly in the hands of an inexperienced
pathologist or trainee.

All lymph nodes submitted must be included for histologic
examination.

Other organs submitted such as prostate and seminal vesicles
or uterus, cervix, vaginal cuff, fallopian tubes and ovaries must
be sampled.
•
Given the high risk of prostatic adenocarcinoma in the age
group undergoing cystectomy for bladder cancer, the highrisk of findings incidental prostatic adenocarcinoma in
cystoprostatectomy specimens17 and the risk of involvement
of the prostate by urothelial carcinoma18, the prostate should
be examined as for a radical prostatectomy for prostate
cancer.
Macroscopic findings
S2.01
The bladder m u s t be measured in three dimensions. The
length of the urethra and ureters should be given. Three
dimensional measurements of any other organs should also be
reported if submitted.
19
CS2.01a
S2.02
The presence of tumour multifocality must be recorded.
CS2.02a
S2.03
The bladder is often accompanied by the prostate, seminal
vesicles or uterus, fallopian tubes, ovaries and vaginal cuff.
The number of foci of tumour must be recorded.
Tumour site(s) must be recorded.
CS2.03a
Tumour site will be one or more of the following (select all
that apply):
•
trigone
•
right lateral wall
•
left lateral wall
•
anterior wall
•
posterior wall
•
dome
•
other (specify)
S2.04
The greatest dimension of the largest tumour and additional
dimensions must be recorded (in mm).
G2.01
The gross appearance of the tumour(s) should be recorded as
polypoid, fungating, papillary, ulcerated or solid and indurated.
S2.05
The presence or absence of macroscopic evidence of bladder
wall and perivesical tissue invasion must be recorded.
CS2.05a
S2.06
S2.07
It is important to identify the maximum level of invasion by
the tumour for accurate staging.
The presence or absence of macroscopic evidence of
involvement of adjacent organs must be recorded.
CS2.06a
This will include the prostate, seminal vesicles, rectum,
uterus/cervix, ovaries fallopian tubes or vagina.
CS2.06a
There is a high risk of prostatic adenocarcinoma in the age
group undergoing cystectomy for bladder cancer, high risk
of finding incidental prostatic adenocarcinoma in
cystoprostatectomy specimens17 and a significant risk of
involvement of the prostate by urothelial carcinoma.18
The presence or absence of macroscopic evidence of resection
margin and peritoneal surface involvement.
CS2.07a
Perivesical, ureteric and urethral margins and peritoneal
surface involvement must be recorded.
CS2.07b
Resection margins are examined to assess the adequacy of
resection. Peritoneal surface involvement may be
associated with peritoneal carcinomatosis.16
CS2.07c
For partial cystectomy specimens, the ureteric and urethral
margin resection may be recorded as “Not applicable”.
20
G2.02
Features of the uninvolved bladder must be recorded.
CG2.02a
Careful examination of apparently uninvolved bladder is
needed to identify multifocal urothelial CIS and foci of
unexpected tumour without a surface papillary component
but directly invasive. Rarely these foci can be more deeply
invasive than a grossly apparent tumour.
S2.08
The number and sites of any lymph nodes submitted must be
recorded.
G2.03
A descriptive or narrative field should be provided to record any
macroscopic information that is not recorded in the above standards
and guidelines, and that would normally form part of the macroscopic
description.
CG2.03a
The traditional macroscopic narrative recorded at the time
of specimen dissection is often reported separately from
the cancer dataset. Although this remains an option, it is
recommended that macroscopic information be recorded
within the overall structure of this protocol.
CG2.03b
Much of the information recorded in a traditional
macroscopic narrative is covered in the standards and
guidelines above and in many cases, no further description
is required.
21
3
Microscopic findings
This section relates to purely histological (morphological) assessment.
Information derived from multiple investigational modalities, or from two or more
chapters, is described in Chapter 5.
S3.01
Histologic type and grade of the invasive component must be
recorded, if present.
CS3.01a
The classification of bladder tumours is from the WHO 2004
classification4 (refer to Appendix 4).
CS3.01b
Urothelial carcinoma is graded as specified in the WHO
classification system.4 Invasive urothelial carcinoma, in
particular variants of invasive urothelial carcinoma, are
typically high grade. Invasive low-grade urothelial carcinoma
is very rare.19
It is possible that some cases, labeled in the past as invasive
low grade UC, are deceptively bland appearing but
aggressive variants such as nested variant of UC.20
S3.02
CS3.01c
Squamous cell carcinoma is graded using criteria used for
these tumours in other viscera.21 Invasive SCC may be well
differentiated with well defined nests of squamous cells with
prominent keratinisation, intercellular bridges and minimal
nuclear pleomorphism, moderately differentiated with more
cellular atypia, minimal keratinisation but with obvious
squamous features or poorly differentiated with marked
nuclear pleomorphism and only focal evidence of squamous
differentiation.
CS3.01d
There is no generally accepted grading system for
adenocarcinoma of the bladder.4
The presence of CIS separate from the invasive component must
be reported.
CS3.02a
G3.01
The approximate percentage of the different tumour subtypes of
urothelial carcinoma should be given.
CG3.01a
S3.03
The extent of bladder CIS may have an impact on the risk of
upper tract recurrence.22
It is likely that the proportion of some variants of urothelial
carcinoma such as micropapillary, plasmacytoid and
sarcomatoid variants will have an impact on prognosis.23-24
The microscopic extent of the tumour must be given.
CS3.03a
Microscopic extent of the tumour must be reported in:
•
Bladder (Refer to Figure 3.03 below)
o
Invades lamina propria
o
Invades inner muscularis propria (Detrusor
22
muscle)
o
Invades outer muscularis propria (Detrusor
muscle)
o
Invades perivesical fat
o
Ureter (specify laterality)
o
Urethra
If submitted, microscopic extent of the tumour must be
reported in:
•
•
Prostate
o
CIS involves prostatic urethra and ducts
o
Carcinoma invades prostatic stroma
Seminal vesicles
o
CIS involving seminal vesicles
o
Carcinoma invades seminal vesicles
•
Rectum
•
Vagina
•
Uterus and adnexae
•
Pelvic sidewall (specify laterality)
•
Other (specify)
CS3.03b
For partial cystectomy specimens, the relationship of the
tumour to structures which are not included in the resection
can be recorded as “Not applicable”.
CS3.03c
Level of invasion or pathological stage is the most important
prognostic indicator in bladder cancer.25
CS3.03d
Involvement of the prostate can be in the form of CIS
involving prostatic urethra and prostatic ducts. This is
considered stage I. If there is direct invasion of the prostate
through muscle invasive bladder cancer, then it is stage 4.13
CS3.03e
Where adenocarcinoma of the prostate is identified, the
protocol for carcinoma of the prostate should be used.
23
Figure S3.03
Assessment of bladder tumour extent
This figure shows the clinical landmarks used to assess the extent of bladder
cancer invasion. Picture courtesy of Kiara Klopfer, BSc, AQUESTA Uropathology.
G3.02
Tumour site(s) should be recorded.
CG3.02a
CG3.02b
Tumour site will be one or more of the following (select all
that apply):
•
trigone
•
right lateral wall
•
left lateral wall
•
anterior wall
•
posterior wall
•
dome
•
other (specify)
A single tumour can involve several of these locations or
there can be separate tumours involving different locations.
G3.03
Tumour size should be recorded as greatest dimension of the largest
tumour.
S3.04
The presence or absence of lymphovascular invasion (LVI) must
be recorded.
S3.05
CS3.04a
Criteria used in other locations also apply here.
CS3.04b
LVI is associated with a higher frequency of metastatic
disease.25
The surgical margin status must be reported.
24
CS3.05a
S3.06
Involvement of ureter and urethral margins by CIS or
invasive carcinoma must be stated. Involvement of
perivesical fat margin and peritoneal surface by invasive
carcinoma must be stated.
Lymph node status must be recorded (if applicable).
CS3.06a
Record the site of any lymph nodes received and state
whether the lymph nodes are involved (positive) or not
(negative). If involved, specify the number of positive nodes
compared with the total number of nodes received.
G3.04
Any co-existing bladder abnormalities should be recorded.
G3.05
Any additional relevant microscopic comments should be recorded.
25
4
Ancillary studies findings
Ancillary studies may be used to determine lineage, clonality or disease
classification or subclassification; as prognostic biomarkers; or to indicate the
likelihood of patient response to specific biologic therapies.
G4.01
Immunohistochemistry could be performed and the results
incorporated into the pathology report.
CG4.01a
While most bladder tumours can be identified on
histological examination, some difficulties may be
encountered in differentiating some subtypes of urothelial
carcinoma from metastatic malignancy. A variety of studies
has investigated the utility of immunohistochemistry in
distinguishing between tumour types and may be helpful in
some cases.
26
5
Synthesis and overview
Information that is synthesised from multiple modalities and therefore cannot
reside solely in any one of the preceding chapters is described here. For example.
tumour stage is synthesised from multiple classes of information – clinical,
macroscopic and microscopic.
By definition, synthetic elements are inferential rather than observational, often
representing high-level information that is likely to form part of the report
‘Summary’ or ‘Diagnosis’ section in the final formatted report.
Overarching case comment is synthesis in narrative format. Although it may not
necessarily be required in any given report, the provision of the facility for
overarching commentary in a cancer report is essential.
S5.01
The pathologic tumour staging category - Primary Tumour (pT)
must be recorded according to the UICC/AJCC TNM
Classification 2010 (Seventh Edition). (See Appendix 5)
S5.02
If lymph nodes are received, the pathologic tumour staging
category (pN) must be recorded according to the UICC/AJCC
TNM Classification 2010 (Seventh Edition). (See Appendix 5)
CS5.02a
Sometimes no lymph nodes are received in the laboratory
and it is not possible to comment on the nodal status; the
presence or absence of metastases or the clinical stage. If
a node dissection is received, it is possible to give an N
stage according to the AJCC guidelines in Appendix 5.
S5.03
The year of publication or the edition of the cancer staging
system used in S5.01 must be included in the report.
G5.01
The “Diagnostic summary” section of the final formatted report should
include:
a. Specimen type
b. Tumour type and grade(S3.01), and whether the tumour is “pure”
or mixed”, with different subtypes specified (G3.01)
c. Tumour extent (Level of invasion) (S3.03)
d. Surgical margin status (completeness of excision) (S3.05)
e. Lymph node involvement (S3.06)
f.
G5.02
Tumour stage (S5.01)
The reporting system must provide a field for free text or narrative in
which the reporting pathologist can give overarching case comment.
CG5.02a
This field may be used, for example, to:
•
document any noteworthy adverse gross and/or
histological features
27
CG5.02b
•
explain any elements of clinicopathological ambiguity
•
express any diagnostic subtlety or nuance that is
beyond synoptic capture
•
document further consultation or results still pending.
Use of this field is at the discretion of the reporting
pathologist.
28
6
Structured checklist
The following checklist includes the standards and guidelines for this protocol
which must be considered when reporting, in the simplest possible form. The
summation of all “Standards” is equivalent to the “Minimum Data Set” for bladder
cancers. For emphasis, standards (mandatory elements) are formatted in bold
font.
S6.01
The structured checklist provided below may be modified as
required but with the following restrictions:
a. All standards and their respective naming conventions,
definitions and value lists must be adhered to.
b. Guidelines are not mandatory but are recommendations and
where used, must follow the naming conventions, definitions
and value lists given in the protocol.
G6.01
G6.02
The order of
according to
described in
Reporting of
CG6.01a
Where the LIS allows dissociation between data entry and
report format, the structured checklist is usually best
formatted to follow pathologist workflow. In this situation,
the elements of synthesis or conclusions are necessarily at
the end. The report format is then optimised independently
by the LIS.
CG6.01b
Where the LIS does not allow dissociation between data
entry and report format, (for example where only a single
text field is provided for the report), pathologists may elect
to create a checklist in the format of the final report. In this
situation, communication with the clinician takes precedence
and the checklist design is according to principles given in
Chapter 7.
Where the checklist is used as a report template (see G6.01), the
principles in Chapter 7 and Appendix 2 apply.
CG6.02a
G6.03
information and design of the checklist may be varied
the laboratory information system (LIS) capabilities and as
Functional Requirements for Structured Pathology
Cancer Protocols.26
All extraneous information, tick boxes and unused values
should be deleted.
Additional comment may be added to an individual response where
necessary to describe any uncertainty or nuance in the selection of a
prescribed response in the checklist. Additional comment is not required
where the prescribed response is adequate.
29
Values in italics are conditional on previous responses.
Values in all caps are headings with sub values.
S/G
Item description
Response type
Conditional
Pre-analytical
S1.01
Demographic information
provided
S1.02
Clinical information
provided on request form
Text
OR
Structured entry as below:
Clinical history
Text
Previous bladder disease
or distant metastasis
Multi select value list (select all that apply):
Clinical extent of disease
•
Superficial bladder disease
•
Muscle invasive disease
•
Distant metastasis
•
No previous bladder disease or metastasis
•
Not stated
Text
30
Details of any previous
therapy
Describe
Surgical procedure
Additional specimens
submitted
Describe
Multi select value list (select all that apply):
•
Radiation therapy
•
Chemotherapy – intravesical
•
Chemotherapy - systemic
•
BCG
•
Other
If other, describe.
Text
Single selection value list:
•
Partial cystectomy
•
Radical cystectomy
•
Cystoprostatectomy
Multi select value list (select all that apply):
•
prostate
•
seminal vesicles
•
uterus
•
fallopian tubes
•
ovaries
•
vaginal cuff
•
other
Text
31
If other, describe
S1.03
Pathology accession
number
Alpha-numeric
S1.04
Principal clinician caring
for the patient
Text
G1.01
Other clinical information
received
Text
Macroscopic findings
S2.01
Bladder measurements
Numeric: __x__x__mm
Notes:
(Superior to inferior x transverse x anterior to posterior)
Length of ureters
Numeric: ___mm (Right)
AND
Numeric: ___mm (Left)
Length of urethra
Numeric: ___mm
Measurements of other
organs eg prostate,
uterus etc
Numeric: __x__x__mm
Conditional on other
organs submitted being
recorded atomically in
S1.02.
Notes:
The measurements should be taken for each other organ
submitted. This may be recorded in S1.02.
32
S2.02
Tumour multifocality
Number of tumours
S2.03
Tumour site(s) in bladder
Details
S2.04
Tumour dimensions
(largest tumour)
Single selection value list:
•
Absent
•
Present
Numeric:____
Multi select value list (select all that apply):
•
trigone
•
right lateral wall
•
left lateral wall
•
anterior wall
•
posterior wall
•
dome
•
other
Text
Numeric: ___mm (largest dimension)
AND
Numeric: ___mm (other dimensions)
G2.01
Gross appearance of
tumour(s)
If present, record the
number of tumours
Multi select value list (select all that apply):
•
Polypoid
•
Fungating
•
Papillary
•
Ulcerated
33
If other, record details
•
Solid and indurated
Notes:
Tumour appearance should be recorded for each tumour
identified in S2.02.
S2.05
Macroscopic evidence of
tumour invasion in
bladder
Tissue(s) invaded
S2.06
Macroscopic evidence of
involvement of adjacent
organs
Single selection value list:
•
Absent
•
Present
If present, record the
tissues invaded
Multi select value list (select all that apply):
•
Bladder wall
•
Perivesical tissue
•
Ureters
•
Urethra
Single selection value list:
•
Absent
•
Present
Conditional on other
organs submitted being
recorded atomically in
S1.02.
If present, record the
organs involved by
tumour
Organs involved by
tumour
Multi select value list (select all that apply):
•
Prostate
•
Seminal vesicles
•
Rectum
34
If other is selected,
specify details.
Details
S2.07
Macroscopic evidence of
margin involvement
Margins involved
G2.02
Appearance of uninvolved
bladder
Details
S2.08
Lymph nodes
•
Uterus/ Cervix
•
Ovaries
•
Fallopian tube
•
Vagina
•
Other
Text
Single selection value list:
•
Absent
•
Present
If present, record the
margins involved
Multi select value list (select all that apply):
•
Perivesical fat margin
•
Peritoneal surface
•
Ureteric
•
Urethral
Multi select value list (select all that apply):
•
Normal
•
Ulcerated
•
Erythematous
•
Other
If other is selected,
specify details.
Text
Single selection value list
35
If submitted, record
site(s) and number of
Site(s) and
number of nodes
•
Submitted
•
Not submitted
nodes
Text: Site
AND
Numeric: Number of LN’s
Notes:
Note that the site and number of LN’s for that site will need
to be repeated for each site received.
G2.03
Other macroscopic comment
Text
Microscopic findings
S3.01
Histologic type and grade
of invasive component
Single selection value list:
•
Pure
•
Mixed
AND
Multi/single* select value list:
If other infiltrating
urothelial carcinoma is
specified, record the
other infiltrating
urothelial carcinoma
type.
Urothelial neoplasms
Infiltrating urothelial carcinoma, high grade
•
Infiltrating urothelial carcinoma, pure
36
If other histologic type is
specified, record the
other histologic type.
•
Squamous differentiation
•
Glandular differentiation
•
Micropapillary
•
Plasmacytoid
•
Sarcomatoid
•
Other infiltrating urothelial carcinoma
Non-Invasive urothelial neoplasms
•
Non-invasive papillary urothelial carcinoma, high
grade
•
Non-invasive papillary urothelial carcinoma, low
grade
•
Non-invasive papillary urothelial neoplasm of low
malignant potential
•
Urothelial papilloma
•
Inverted urothelial papilloma
Squamous neoplasms
•
Squamous cell carcinoma
•
Verrucous carcinoma
37
If squamous cell
carcinoma is selected
record the SCC grade.
•
Squamous cell papilloma
Glandular neoplasms
•
Adenocarcinoma
o
Not otherwise specified
o
Enteric
o
Mucinous
o
Signet ring cell
o
Clear cell
o
Mixed
Neuroendocrine neoplasms
•
Small cell carcinoma
•
Carcinoid
•
Paraganglioma
Other histologic type
Note
*Note that if pure is selected above then only a single type
should be selected here.
38
Other infiltrating
urothelial carcinoma
Text
Other histologic type
Text
SCC grade
S3.02
G3.01
S3.03
CIS separate to invasive
component
Percentage of tumour
subtypes of urothelial
carcinoma
Single selection value list:
•
Well differentiated
•
Moderately differentiated
•
Poorly differentiated
Single selection value list:
•
Not identified
•
Present
For each of the subtypes below record the percentage:
•
Micropapillary:___% (Percentage of this type)
•
Plasmacytoid:___% (Percentage of this type)
•
Sarcomatoid:___% (Percentage of this type)
EXTENT OF TUMOUR
MICROSCOPIC INVASION
OF BLADDER
39
Conditional on one or
more of micropapillary,
plasmacytoid and
sarcomatoid urothelial
carcinoma being
identified in S3.01.
Lamina propria invasion
Inner muscularis propria
(Detrusor muscle)
invasion
Outer muscularis propria
(Detrusor muscle)
invasion
Perivesical fat invasion
Ureters
Single selection value list:
•
Absent
•
Present
•
Not applicable
Single selection value list:
•
Absent
•
Present
•
Not applicable
Single selection value list:
•
Absent
•
Present
•
Not applicable
Single selection value list:
•
Absent
•
•
Present
Not applicable
Single selection value list:
•
Absent
•
CIS present
•
Invasive UC present
•
CIS and invasive UC present
•
Not applicable
40
If CIS present, Invasive
UC present or CIS and
invasive UC present then
specify laterality
Laterality
Urethra
Single selection value list:
•
Left
•
Right
•
Left and Right
Single selection value list:
•
Absent
•
CIS present
•
Invasive UC present
•
CIS and invasive UC present
•
Not applicable
MICROSCOPIC INVASION
OF OTHER ORGANS
Prostate
Seminal vesicles
Conditional on other
organs submitted being
recorded atomically in
S1.02.
Multi select value list (select all that apply):
•
Absent
•
CIS in urethra or ducts
•
Invasive carcinoma in prostatic stroma
Multi select value list (select all that apply):
•
Absent
•
CIS
•
Invasive carcinoma
41
Rectum
Single selection value list:
Uterus
•
Absent
•
Present
Single selection value list:
Fallopian tubes
•
Absent
•
Present
Single selection value list:
•
Absent
Present
Ovaries
Single selection value list:
•
Absent
Present
Vagina
Single selection value list:
•
Absent
Present
Pelvic side wall
Single selection value list:
Laterality
•
Absent
•
Present
Single selection value list:
•
Left
•
Right
•
Left and Right
42
If present, specify
laterality
Other organ invasion
Organ invaded
G3.02
Tumour site(s)
Other tumour site(s)
Single selection value list:
•
Absent
•
Present
Text
Multi select value list (select all that apply):
•
trigone
•
right lateral wall
•
left lateral wall
•
anterior wall
•
posterior wall
•
dome
•
other
If other selected record
the other tumour site(s)
Text
G3.03
Tumour size
Numeric: ____mm (maximum dimension of the largest
tumour)
S3.04
Lymphovascular invasion
Single selection value list:
S3.05
If present, specify the
other organ invaded.
•
Not identified
•
Present
SURGICAL MARGIN
STATUS
Ureter
Single selection value list:
43
Conditional on radical
cystectomy being
•
Negative
•
Positive
recorded atomically in
S1.02.
If positive, record type of
involvement
Type of involvement
Urethra
Single selection value list:
•
CIS
•
Invasive carcinoma
•
CIS and invasive carcinoma
Single selection value list:
•
Negative
•
Positive
Conditional on radical
cystectomy being
recorded atomically in
S1.02.
If positive, record type of
involvement
Type of involvement
Perivesical fat margin
Single selection value list:
•
CIS
•
Invasive carcinoma
•
CIS and invasive carcinoma
Single selection value list:
•
Negative
Positive
44
Peritoneal surface
Single selection value list:
•
Negative
Positive
Other margin
Text: State specific margin
AND
Single selection value list:
•
Negative
•
Positive
Notes:
Note that the margin and whether it is positive or negative
may need to be repeated for each other margin.
S3.06
Lymph node status
Text: Site
AND
Single selection value list:
Conditional on lymph
nodes being submitted in
S2.08.
Notes:
Note that the site of
lymph nodes received
and the number of lymph
nodes at each site has
been recorded in S2.08.
Note that the site and whether the lymph nodes are
positive or negative for that site will need to be repeated
for each site received in S2.08.
If positive, record the
number of positive lymph
nodes on microscopic
•
Negative
•
Positive
45
evaluation.
Number of positive nodes
Numeric: ___/____
Notes:
Number of positive nodes/Number of nodes from this site
G3.04
Co-existing bladder
abnormalities
Text
G3.05
Other microscopic comment
Text
Ancillary test findings
G4.01
IMMUNOHISTOCHEMICAL
STAINS
Performed
Antibodies
Single selection value list:
•
No
•
Yes
List (as applicable) all:
•
Positive antibodies
•
Negative antibodies
•
Equivocal antibodies
46
If yes, record antibodies.
Synthesis and overview
S5.01
AJCC Tumour staging
category (pT)
Single selection value list:
TX
T0
Ta
Tis
T1
T2
T2a
T2b
T3
T3a
T3b
T4
T4a
T4b
Primary tumour cannot be assessed
No evidence of primary tumour
Non-invasive papillary carcinoma
Carcinoma in situ: “flat tumour”
Tumour invades subepithelial connective tissue
Tumour invades muscularis propria
Tumour invades superficial muscularis propria
(inner half)
Tumour invades deep muscularis propria (outer
half)
Tumour invades perivesical tissue
microscopically
macroscopically (extravesical mass)
Tumour invades any of the following: prostatic
stroma, seminal vesicles, uterus, vagina, pelvic
wall, abdominal wall
Tumour invades prostatic stroma, uterus, vagina
Tumour invades pelvic wall, abdominal wall
Notes:
The extent of primary tumour is usually classified after
radical cystectomy and, for this reason, a pathologic stage
is assigned.
47
S5.02
AJCC Tumour staging
category (pN)
Single selection value list:
NX
N0
N1
N2
N3
Lymph nodes cannot be assessed
No lymph node metastasis
Single regional lymph node metastasis in the true
pelvis (hypogastric, obturator, external iliac or
presacral lymph node)
Multiple regional lymph node metastasis in the
true pelvis (hypogastric, obturator, external iliac or
presacral lymph node metastasis)
Lymph node metastasis to the common iliac lymph
nodes
Notes:
Regional lymph nodes include both primary and secondary
drainage regions. All other nodes above the aortic
bifurcation are considered distant lymph nodes.
S5.03
G5.01
Year and edition of
staging system
Diagnostic summary
Numeric: year
AND
Text: Edition eg 1st, 2nd etc
Text
Include:
a. Specimen type
b. Tumour type and
grade(S3.01), and
whether the tumour is
“pure” or mixed”, with
48
Conditional on lymph
nodes being submitted in
S2.08
different subtypes
specified (G3.01)
c. Tumour extent (Level of
invasion) (S3.03)
d. Involvement of surgical
margin (completeness of
excision) (S3.05)
e. Lymph node involvement
(S3.06)
a. Tumour stage (S5.01)
G5.02
Overarching comment
Text
49
7
Formatting of pathology reports
Good formatting of the pathology report is essential for optimising communication
with the clinician, and will be an important contributor to the success of cancer
reporting protocols. The report should be formatted to provide information clearly
and unambiguously to the treating doctors, and should be organised with their
use of the report in mind. In this sense, the report differs from the structured
checklist, which is organised with the pathologists’ workflow as a priority.
Uniformity in the format as well as in the data items of cancer reports between
laboratories makes it easier for treating doctors to understand the reports; it is
therefore seen as an important element of the systematic reporting of cancer. For
guidance on formatting pathology reports, please refer to Appendix 2.
50
Appendix 1
Pathology request
information and surgical
handling procedures
This appendix describes the information that should be collected before the
pathology test. Some of this information can be provided on generic pathology
request forms; any additional information required specifically for the reporting of
bladder cancer may be provided by the clinician on a separate request
information sheet. An example request information sheet is included below.
Elements which are in bold text are those which pathologists consider to be
required information. Those in non-bold text are recommended.
Also included in this appendix are the procedures that are recommended before
handover of specimens to the laboratory.
Patient information

Adequate demographic and request information should be
provided with the specimen.
•
Items relevant to cancer reporting protocols include:
i
ii
patient name
date of birth
iii sex
iv identification and contact details of requesting doctor
v
•

date of request
The patient’s ethnicity should be recorded, if known. In particular
whether the patient is of aboriginal or Torres Strait islander origin.
This is in support of a government initiative to monitor the health
of indigenous Australians particularly in relation to cancer.
The patient’s health identifiers should be provided.
•
The patient’s health identifiers may include the patient’s Medical
Record Number as well as a national health number such as a
patient’s Medicare number (Australia), Individual Healthcare
Identifier (IHI) (Australia) or the National Healthcare Identifier
(New Zealand).
Clinical Information

Clinical history should be recorded.
51
•

Relevant past medical history, family history and known risk
factors associated with bladder cancers should be provided.
The past history of urothelial neoplasms elsewhere in the
urinary tract should be recorded.
Previous history of bladder disease or presence of distant
metastasis should be recorded.
•
Previous history of bladder disease may include:
•
•

•
Distant metastasis refers to the spread of cancer of the same
histologic type as the original (primary) tumour to distant organs
or distant lymph nodes.
•
This information will provide an opportunity for previous reports to
be reviewed during the reporting process, which may provide
valuable information to the pathologist. This information also has
implications for recording cancer incidence and evidence based
research.
Information regarding the extent of disease as determined from clinical
assessment, cystoscopy, prior histology and imaging should be provided.
•


Superficial bladder disease
Muscle invasive disease.
Relevant information regarding the extent of disease, particularly
biopsy positivity gives extra information that is useful for
adequately sampling for accurate staging. For example, the
principal tumour may not be the most invasive. There may be
non-papillary tumours that are deeply invasive.
Information regarding relevant previous therapy such as BCG,
radiation therapy and chemotherapy, both intravesical and
systemic, should be recorded.
•
Previous chemotherapy may cause extensive or complete tumour
necrosis. This must be taken into account by the reporting
pathologist.
•
Chemotherapy or radiation therapy induced changes may simulate
malignancy. For example, radiation therapy or chemotherapy can
produce pseudo-carcinomatous urothelial proliferation mimicking
invasive urothelial or squamous cell carcinoma27 or CIS-like
changes.28
The surgical procedure and nature of the specimen should be
stated.
•
Whether the surgical procedure is a radical or partial cystectomy
or cystoprostatectomy must be stated.
•
Any additional organs submitted should be identified (select all
that apply):
•
prostate
52
•
seminal vesicles
•
uterus
•
fallopian tubes
•
ovaries
•
vaginal cuff
•
other (specify)
53
Example Request Information Sheet
The above Request Information Sheet is published to the RCPA website.
54
Appendix 2
Guidelines for formatting of
a pathology report
Layout
Headings and spaces should be used to indicate subsections of the report, and
heading hierarchies should be used where the LIS allows it. Heading hierarchies
may be defined by a combination of case, font size, style and, if necessary,
indentation.
•
Grouping like data elements under headings and using ‘white space’
assists in rapid transfer of information.29
Descriptive titles and headings should be consistent across the protocol, checklist
and report.
When reporting on different tumour types, similar layout of headings and blocks
of data should be used, and this layout should be maintained over time.
•
Consistent positioning speeds data transfer and, over time, may reduce
the need for field descriptions or headings, thus reducing unnecessary
information or ‘clutter’.
Within any given subsection, information density should be optimised to assist in
data assimilation and recall.
•
•
•
Configuring reports in such a way that they ‘chunk’ data elements into a
single unit will help to improve recall for the clinician.29
‘Clutter’ should be reduced to a minimum.29 Thus, information that is not
part of the protocol (e.g. billing information, SNOMED codes, etc) should
not appear on the reports or should be minimized.
Injudicious use of formatting elements (e.g. too much bold, underlining or
use of footnotes) constitutes clutter and may distract the reader from the
key information.
Where a structured report checklist is used as a template for the actual report,
any values provided in the checklist but not applying to the case in question must
be deleted from the formatted report.
Reports should be formatted with an understanding of the potential for the
information to mutate or be degraded as the report is transferred from the LIS to
other health information systems.
As a report is transferred between systems:
•
•
•
•
text characteristics such as font type, size, bold, italics and colour are
often lost
tables are likely to be corrupted as vertical alignment of text is lost when
fixed font widths of the LIS are rendered as proportional fonts on screen or
in print
spaces, tabs and blank lines may be stripped from the report, disrupting
the formatting
supplementary reports may merge into the initial report.
55
Appendix 3
Example of a pathology
report
Citizen, Georgina
Lab Ref:
C/O Paradise Close
Wreck Bay Resort
Nar Nar Goon East, 3181
Female
DOB
MRN
1/7/1962
M1196785
11/P28460
Referred:
Copy to: Dr N.G.Chappie
Rainforest Cancer Centre.
46 Smith Road,
Woop Woop, 3478
30/8/2011
Referred by: Dr V. Brown
Suite 3, AJC Medical Centre,
Bunyip Crescent
Nar Nar Goon West, 3182
BLADDER CANCER STRUCTURED REPORT
Page 1 of 2
Diagnostic Summary
Radical cystectomy: High grade urothelial carcinoma, invading
into lamina propria and outer muscularis propria, clear surgical
margins , Pathological Stage pT2b (AJCC 7th edition, 2010)
Supporting Information
CLINICAL
Clinical History:
Haematuria
Clinical extent of disease:
Muscle invasive high grade TCC found on left
lateral bladder biopsy
Details of previous therapy:
Nil
Surgical procedure:
Radical cystectomy
Additional specimens:
Nil
Prev. bladder disease/distant metastasis: No previous bladder disease or metastasis
MACROSCOPIC
Bladder measurements:
80 mm in length x 65 mm in transverse
dimension x 45mm anterior to posterior
Length of ureters:
Right 45 mm, Left 55 mm
Length of urethra:
7mm
Tumour multifocality:
Absent
Tumour site(s) in bladder:
Left lateral wall, posterior wall, dome
Tumour dimensions:
42mm (largest dimension) x 19mm x 6mm
Gross appearance of tumour(s):
Ulcerated, Solid and indurated, white
Evidence of tumour invasion:
Present into bladder wall
Evidence of margin involvement:
Absent
Appearance of uninvolved bladder:
Normal
Lymph nodes:
Not submitted
56
Page 2 of 2
MICROSCOPIC
Tumour
Histologic type and grade:
Pure, infiltrating urothelial carcinoma, high
grade
CIS separate to invasive component:
Absent
Tumour site(s):
Left lateral wall, posterior wall, dome
Tumour size:
42mm
Extent
INVASION OF BLADDER
Lamina propria invasion:
Present
Inner muscularis propria invasion:
(Detrusor muscle)
Present
Outer muscularis propria invasion:
(Detrusor muscle)
Present
Perivesical fat invasion:
Absent
Ureters:
Absent
Urethra:
Absent
Lymphovascular invasion:
Present
Margins
Ureter:
Negative
Urethra:
Negative
P e r iv e s ic a l fa t m a r g in :
Negative
P e r it o n e a l s u r f a c e :
Negative
Lymph nodes
None submitted
Co-existing bladder abnormalities:
Nil
ANCILLARY TESTS
None performed
57
Appendix 4 WHO Classification of Tumours
of the Bladder Carcinoma4
Urothelial tumours
Infiltrating urothelial carcinoma
with squamous differentiation
with glandular differentiation
with trophoblastic differentiation
Nested
Microcystic
Micropapillary
Lymphoepithelioma-like
Lymphoma-like
Plasmacytoid
Sarcomatoid
Giant cell
Undifferentiated
Non-invasive urothelial neoplasias
Urothelial carcinoma in situ
Non-invasive papillary urothelial carcinoma, high grade
Non-invasive papillary urothelial carcinoma, low grade
Non-invasive papillary urothelial neoplasm of low
malignant potential
Urothelial papilloma
Inverted urothelial papilloma
8130/1
8120/0
8121/0
Squamous neoplasms
Squamous cell carcinoma
Verrucous carcinoma
Squamous cell papilloma
8070/3
8051/3
8052/0
8120/3*
8131/3
8082/3
8122/3
8031/3
8020/3
8120/2
8130/23
8130/21
Glandular neoplasms
Adenocarcinoma
Enteric
Mucinous
Signet-ring cell
Clear cell
Villous adenoma
8480/3
8490/3
8310/3
8261/0
Neuroendocrine tumours
Small cell carcinoma
Carcinoid
Paraganglioma
8041/3
8240/3
8680/1
8140/3
Melanocytic tumours
Malignant melanoma
Nevus
8720/3
Mesenchymal tumours
Rhabdomyosarcoma
Leiomyosarcoma
Angiosarcoma
Osteosarcoma
8900/3
8890/3
9120/3
9180/3
58
Malignant fibrous histiocytoma
Leiomyoma
Haemangioma
Other
8830/3
8890/0
9120/0
Haematopoietic and lymphoid tumours
Lymphoma
Plasmacytoma
9731/3
Miscellaneous tumours
Carcinoma of Skene, Cowper and Littre glands
Metastatic tumours and tumours extending from other organs
* Morphology code of the International Classification of Diseases for Oncology
(ICD-O) and the Systematized Nomenclature of Medicine (http://snomed.org).
Behaviour is coded /0 for benign tumours, /2 for in situ carcinomas and grade III
intraepithelial neoplasia, /3 for malignant tumours, and /1 for borderline or
uncertain behaviour.
From: Eble, JN, Sauter, G, Epstein JI, Sesterhenn IA. World Health Organization
Classification of Tumours. Pathology and Genetics of Tumours of the Urinary
System and Male Genital Organ. Volume 7. IARC, Lyon, 2004.
59
Appendix 5
AJCC Cancer Staging System
TNM Descriptors
(required only if applicable) (select all that apply)
m (multiple primary tumours)
r (recurrent)
y (post treatment)
AJCC primary tumour definitions.
1
Primary Tumour (pT)
TX
Primary tumour cannot be assessed
T0
No evidence of primary tumour
Ta
Non-invasive papillary carcinoma
Tis
Carcinoma in situ: “flat tumour”
Tumour invades subepithelial connective tissue
T1
T2
Tumour invades muscularis propria
T2a
Tumour invades superficial muscularis propria (inner half)
T2b
Tumour invades deep muscularis propria (outer half)
T3
Tumour invades perivesical tissue
microscopically
T3a
T3b
macroscopically (extravesical mass)
Tumour invades any of the following: prostatic stroma, seminal
T4
vesicles, uterus, vagina, pelvic wall, abdominal wall
T4a
Tumour invades prostatic stroma, uterus, vagina
T4b
Tumour invades pelvic wall, abdominal wall
AJCC regional lymph node classifications.1
Regional Lymph Nodes (pN)
Regional lymph nodes include both primary and secondary drainage regions. All
other nodes above the aortic bifurcation are considered distant lymph nodes.
NX
Lymph nodes cannot be assessed
No lymph node metastasis
N0
Single regional lymph node metastasis in the true pelvis
N1
(hypogastric, obturator, external iliac or presacral lymph node)
Multiple regional lymph node metastasis in the true pelvis
N2
(hypogastric, obturator, external iliac or presacral lymph node
metastasis)
Lymph node metastasis to the common iliac lymph nodes
N3
1
Used with the permission of the American Joint Committee on Cancer (AJCC),
Chicago, Illinois. The original source for this material is the AJCC Cancer Staging
Manual, Seventh Edition (2010) published by Springer Science and Business
Media LLC, www.springerlink.com.
60
AJCC distant metastases classifications.2
Distant Metastasis (pM)
M0
No distant metastasis
M1
Distant metastasis
AJCC Anatomical Stage/Prognostic Groups2
Group
T
N
M
Stage 0a
Ta
N0
M0
Stage Ois
Tis
N0
M0
Stage I
T1
N0
M0
Stage II
T2a
N0
M0
T2b
N0
M0
T3a
N0
M0
T3b
N0
M0
T4a
N0
M0
T4b
N0
M0
Any T
N1-3
M0
Any T
Any N
M1
Stage III
Stage IV
2
Used with the permission of the American Joint Committee on Cancer (AJCC),
Chicago, Illinois. The original source for this material is the AJCC Cancer Staging
Manual, Seventh Edition (2010) published by Springer Science and Business
Media LLC, www.springerlink.com.
61
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